Recall Z-0350-2020— Privapath Diagnostics Ltd
Class II · Terminated
Class II FDA medical device recall by Privapath Diagnostics Ltd, initiated 2019-07-01, terminated 2020-11-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Universal Sexual Health Testing Kit. Reason: A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio..
- Recalling firm
- Privapath Diagnostics Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-01
- Terminated
- 2020-11-23
- Firm location
- Dublin 12, N/A, Ireland
Product description
Universal Sexual Health Testing Kit
Reason for recall
A supplier informed PrivaPath Diagnostics that there is a potential for damaged tubes which could result in blood exposure or erroneous results due to an inappropriate blood-to-additive ratio.
Data sourced from openFDA. This site is unofficial and independent of the FDA.